A Medical Device Daily

CryoLife (Atlanta), an implantable biological medical device and cardiovascular tissue processing company, reported the first three implantations of the CryoPatch SG pulmonary human cardiac patch since FDA clearance earlier this month (MDD, Aug. 13, 2009).

CryoPatch SG is the third tissue processed using CryoLife's SynerGraft technology platform to receive FDA clearance. The technology is designed to remove allogeneic donor cells and cellular remnants from tissue without compromising the integrity of the underlying collagen matrix.

CryoPatch SG is indicated for the repair or reconstruction of the right ventricular outflow tract (RVOT), which is a surgery commonly performed in children with congenital heart defects, such as Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.

Implantation of the CryoPatch SG reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody (PRA) measured at up to one year, compared to standard processed pulmonary cardiac tissues. Data have not been provided to evaluate the effect of reduced alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoPatch SG.

"At CryoLife, our ongoing goal is to provide surgeons and their patients with innovative options that will enhance recovery and restore health," said Steven Anderson, CryoLife's president/CEO. "The CryoPatch SG, part of our growing portfolio of SynerGraft products, is an important step toward that goal, as it may offer a tissue reconstruction material that mitigates many of the future health issues faced by children born with heart defects."